So, myself and my friend Stephanie were in Chicago this week. We had traveled across the Atlantic to hear the opening arguments of Dolin v. Smithkline Beecham Corp (now GlaxoSmithKline – GSK). For more background to this case, see here.

We arrived straight into an unprecedented weather event, Storm Stella – described in the media as a weather bomb, having undergone bombogenesis (haven’t a clue either). Thus, while we were a little worried that the trial might be postponed, we were more concerned with the liklihood of two Irish females freezing to death. However, despite hitting a cool minus-8, with some pretty bizarre white-out conditions, we survived and the trial went ahead as planned (with the Hon. William T. Hart presiding).

This case centers on Wendy Dolin, the plaintiff, alleging that her husband’s death in 2010 was drug-induced and that GSK failed to warn of the increased risk of suicide in older adults taking the antidepressant Paroxetine. Her lawyers, Baum Hedlund, contend that GSK hid a ‘dirty little secret’ – that the drug can cause akathisia, often coded under the innocuously-sounding ‘inner turmoil’. However, this drug-induced condition is far from harmless and injury to oneself and/or others, can quickly follow. Furthermore, as alleged in this case, it can often prove fatal; see here.

At the time of his death, Stewart Dolin was 57 and was a corporate lawyer with ReidSmith. While suffering from work-related stress, he was prescribed Paroxetine by his physician, Dr. Martin Sachman – a family friend. Paroxetine is perhaps more widely recognised by its trade name Paxil, or Seroxat in Europe. Six days after being prescribed a generic form of the drug, Stewart died by jumping in front of a Chicago train. He was affluent, well-liked by colleagues and well-loved by his family. Per one of his colleagues “Stu Dolin was a close personal friend, valued colleague and a great leader in our firm. His energy and spirit benefited everyone around him. The lawsuit claims that GSK failed to adequately warn doctors (including Dr. Sachman) of the increased risk of suicidal behavior in adults. Indeed, GSK’s opening argument proclaimed that ‘Paxil does not cause suicide’. That was then contradicted by GSK’s very own literature, where a 2006 analysis showed a 6.7 times greater risk of suicidal behaviour in adults (of all ages) taking Paxil, over placebo.

Doctor David Healy was on the stand for 2 full-days, as an expert witness for the plaintiff. His testimony included an account of how GSK had hidden suicide events from the Food and Drug Administration (FDA), thus manipulating the suicide-ratio and effectively hiding the bodies. Explaining drug-induced suicides to the jury, his world-leading expert status in psychopharmacology was unquestionable. No doubt, GSK ‘s legal team will attempt to annihilate that particular status before he exposes any more ‘dirty little secrets’. Like how 100% of Paxil consumers will experience sexual dysfunction – another life changing adverse-effect he mentioned in court, and another one not precisely admitted to by the manufacturers.

Not surprisingly, GSK’s lawyers (King and Spalding), became increasingly apoplectic, interjecting every few minutes with their objections, which proved fascinating in itself. The last hour before the court adjourned for the week-end proved to be very enlightening indeed, with their team looking increasingly agitated. Doctor Healy was then asked some questions by the plaintiff’s legal team:

(1) Do you have any doubt that Paxil can cause suicide? He answered ‘No’.

(2) In your opinion, did GSK warn doctors of the increased risk of suicide in adults? Again he answered ‘No’.

There seemed little doubt to anyone listening that Paxil could cause Akathisia and/or a drug-induced suicide. However, no doubt GSK will have many experts to refute that, whatever the evidence has shown. Having listened to this week’s testimonies, there is absolutely no doubt in my mind that Steward Dolin’s death was induced by the Paxil he was taking in the final 6 days of his life. However, the trial will most-likely go on for another few weeks when the jury will ultimately decide. Sadly, as is normal in these legal cases, every aspect of Wendy and Stewart’s private life will be publicly torn to shreds, with their every move dissected to try and put doubt into the jury’s mind. Whatever the outcome, Stewart’s wife Wendy, is one very, very brave lady.

Clearly, GSK’s lawyers are particularly polished and well used to court proceedings. That said, following the jurys’ retirement for the weekend, there was a last minute crucial objection from their legal team. One of their lawyers raised a final grievance – that a lawyer for the plaintiff’s side had the cheek to say ‘have a good weekend’ to the jury. Seriously? Drug induced suicide was the issue here and this farewell gesture caused offence to GSK’s legal team?

Anyway, if you would like to see the three video depositions that were shown to the court; they were uploaded yesterday. You really don’t need to be a body language expert to determine how truthful these GSK experts are being – or not.

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Note to Ben Goldacre (from me):

Maybe Ben should have a chat with Greg Thorpe (the GSK whistle-blower behind the 3 Billion dollar fine), Greg regularly contributes to this blog (see here). I’m sure that Greg could open Ben’s eyes to the reality of GSK’s nefarious conduct because it seems that my blog posts fall on deaf ears where Ben is concerned.

“….Missing data poisons the well for everybody. If proper trials are never done, if trials with negative results are withheld, then we simply cannot know the true effects of the treatments we use. Evidence in medicine is not an abstract academic preoccupation. When we are fed bad data, we make the wrong decisions, inflicting unnecessary pain and suffering, and death, on people just like us….”

“…As one of the authors of the RIAT restoration of Paxil Study 329 who was around for the whole process, I don’t actually know the answer to Leonie’s question about why it was so hard to get our paper published.

I don’t know if a Conflict of Interest had anything to do with that, but in a way, that’s the whole point – when there’s a significant Conflict of Interest, you can’t ever really know.

It’s a variable that can’t be evaluated.

So her question stands whether it can be answered or not. Should the original Study 329 report be retracted?

That’s not in our hands.

My choice would be that it should never have been published in the first place..”

There is a fascinating debate happening over on Dr David Healy’s blog about a lecture which Dr Ben Goldacre gave in Dublin’s Royal College of Surgeons last week. It all started when (patient activist, and blogger) Leonie Fennell (an attendee of the lecture)- published her opinion of Ben’s talk in a post on Dr Healy’s blog (titled ‘Club 329‘). The post seems to be sparking some very interesting reactions, not least from Ben Goldacre himself (who incidentally has already accused Dr. Healy of misrepresenting his views because the post is published on Healy’s web-page).

Personally I don’t think that Leonie misrepresented Ben at all, and ironically, Ben claims that the audio of the lecture itself confirms this misrepresentation, when in fact- it does the opposite: it upholds, and confirms Leonie’s views.

Club 329: Part 1

Editorial Note: This post is by Leonie Fennel. It’s one of two involving Leonie.

Last week, Dr Ben Goldacre gave a public lecture in the Royal College of Surgeons in Dublin (organised by the 3U Partnership and the very lovely Dr Ruth Davis). Dr Goldacre is a doctor, academic, campaigner and writer; he is also a psychiatrist and self-professed nerd. I was eager to hear what he had to say, not least as the subject-matter was ‘Bad Trials’ – so off I toddled to Stephen’s Green with a friend in tow, a psychotherapist. He, like me, has a personal interest – he has witnessed first-hand the devastation that can be caused by nothing more than a GP’s farraginous prescribing. He is also a very kind, funny, charming companion, so I was delighted to have any excuse to meet up with him. I’d also say he’s a handsome chap but the husband I abandoned for the day wouldn’t be too impressed.

Having read Goldacre’s ‘Bad Pharma’ book, we were both curious to hear what he had to say. Incidentally, he once called my English friend Fid a ‘Smeary Conspiracy Theorist’ – so apart from guaranteed entertainment, I wasn’t too sure what else to expect. In fact, his talk was fast-paced and as excitable as he is – he hops around like a Duracell bunny on speed and lets out intermittent roars, which effectively kick-starts the heartbeats of anyone not paying attention. Nevertheless, he attempts to make data and statistics fun, a nigh-on impossible task.

Needless to say, as the subject concerned ‘bad-trials’, he specifically mentioned GlaxoSmithKline’s notorious Study 329, although bizarrely managed to do so without mention of GSK (usually both are referenced synonymously). He seemed like an amicable chap and was quite happy to answer questions afterwards in the Q & A session.

I was interested to explore his views on Study 329 and asked his opinion on why the BMJ took a year (of much wrangling) to publish Le Noury et al’s reanalysis of it – and did he think it had anything to do with the BMJ’s clinical editor being married to a partner in Ropes and Gray, the same law-firm hired by GSK to defend the action brought by the US Dept. of Justice, where Study 329 was a central element.

Goldacre said that he didn’t know and didn’t care – that fraud and Conflicts of Interest were not of interest to him. He asked what the fixation with Study 329 was, as it was just one of the many trials where data was misrepresented?

He expressed the opinion that everyone knew from early on that the original study 329 was flawed and nobody really relied on it. I sincerely doubt that the authors would agree with him on that, but he is entitled to his opinion. The oddity as the photo shows he was talking about outcome switching which is what happened in this originally well-designed trial.

He went on to say that the reanalysis (Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence) was nothing new. It only did what had largely been done before and confirmed what everyone actually already knew.

Expressing my concerns that Study 329 was still not retracted, he asked what I wanted to happen, that all papers that are re-analysed and found wanting, be retracted? Erm, yes!

My friend, the dishy therapist, then said that wasn’t the crucial point being that 329 harmed so many children? Ben said once people have informed consent, they can make their own choices – like this is a common practice. He pushed Ben on the now-common practice of problematizingdistress, with Ben suggesting that people need to be careful not to push their own biases onto others.

It struck me as odd that BG seemed disturbed by the discussion turning to study 329 – yet he had specifically brought it up himself. I thought it even odder that he didn’t give the re-analysis by Le Noury et al any credit at all. I got the distinct impression that while his forte may be in data and stats, the enormous numbers harmed by these fraudulent trials were given little consideration.

How can anyone say that people can make an autonomous choice to take a drug, when the (usually ghost-written) studies are manipulated to give positive results, while hiding serious harms?

The mammoth undertaking by Le Noury et al deserves huge recognition for exposing just this – that truly informed consent is impossible unless the full facts are provided.

Editor’s Note: Ben Goldacre has taken exception to this characterization. He comments below. His tweets on the issue can be foundBG tweets

Leonie has made some very important points in her post, in particular her last point about ‘truly informed consent is impossible unless the full facts are provided’.

Informed consent can only occur if patients are given the full facts about the drugs that they take- the thrust of Ben’s argument in regards to clinical trial data over the years has been just that: we don’t have the full picture about the drugs that we take.

Some trials are missing, some trials are doctored to make the drugs look more favorable than they are, and in other cases, (such as with Seroxat study 329) drug trial results show harms, but these harms are hidden, obscured or repressed, and often the harms are spun as positives. This type of thing can lead to deaths of patients, or as in the case of study 329, millions of teens were exposed to a drug that we now know is extremely harmful in that age group.

(One of those teens whose life was taken by Seroxat was Sharise Gatchell, a talented young artist, see more here).

So, if we can’t trust the drugs, because the trials are incomplete, and in many cases just shoddy and dodgy, and if the the pharmaceutical companies won’t give access to the raw data (and Ben’s Alltrials aren’t looking for access to the data anyhow), then surely we cannot trust that we are given full informed consent before we choose to take a drug can we?

Furthermore, in regards to psychiatric drugs, these problems of (mis) informed consent become even more complex, particularly in regards to efficacy and safety, because with psychiatric drugs, the so called ‘benefits’ are much more subjective, because we are dealing with the mind, emotions, the individual’s psyche etc. The effects of psych drugs, and how a patient might respond to being given a drug to treat their condition, relies entirely upon subjectivity and how a patient interprets any perceived fluctuation in mood etc.

You can’t measure serotonin levels, for example, and even if you could it’s debatable whether interfering with serotonin levels has any benefit in a depressed, anxious or ‘mentally ill’ patient anyhow. These theories have never been scientifically validated, and it’s doubtful that they ever will be. In fact, psychiatry is trying to distance itself from these theories nowadays, whereas merely a decade ago the psychiatric profession thought nothing of heavily promoting the chemical imbalance theory in order to sell more meds (and align themselves with the drug company propaganda and misinformation at the time).

According to Ben, the picture of efficacy for psychiatric drugs (and most other drugs too) is incomplete, therefore I find it difficult to understand why he then claims that there’s some kind of informed choice going in regards to the prescribing of these drugs when clearly the whole basis of his work to date has been to inform us that we are being misinformed about the drugs we are prescribed?

In the following extract, from the recording of the Q and A, Ben reiterates his view that there is informed choice when it comes to treating mental illness with psychiatric drugs (anti-psychotics and anti-depressants).

“…Can I just ask another question, because I find it this stuff interesting- You’re talking about antipsychotics and antidepressants, and you know, the dodginess of some of the trials, but, do you not think medicalizing human distress is also the bigger problem?…

Ben Goldacre:

“…That’s about informed choice. So I get a sense of, that maybe you’re coming from kind of a particular standpoint on mental health and that’s a partial view but I think with, with any treatment, the right thing to do is to say, look, for the problems that you have, there is very good evidence, that this is intervention which exists, which is been invented, which is available on prescription.

“…From the best evidence we have, overall it looks like it has the following benefits and the following harms and it’s for you to choose whether you’d like to take it. Now that works really well for most treatments, except it’s not done properly. So first of all you need to get better at disseminating information not just to doctors but also patients..”

“…So different people make different choices on the basis of the same information and I don’t know if it’s for me, to bring my own personal views and prejudices, which are actually, between you and I, and the room, more aligned to yours, than to most of the psychiatric profession, but I don’t think it’s for me to bring my own prejudices to bear on that. I think it’s for me to help my patients make an informed choice on the basis of the best currently available evidence and if they want to take an antidepressant, where the best currently available evidence shows that it will reduce your depression by by 2 out of 30 points, which is a modest, but nonetheless true benefit – then, that’s a choice for them to make, it’s not for me to bring my prejudices about medicalization of society to bear on that. That, that’s a choice for them…”

Personally I think Ben is living in cloud cuckoo land.

He wants to have his cake and eat it. He wants to come across as a patient advocate, but is afraid to rock the boat in his own profession too much, because he is firmly on the side of the establishment mind set which is of course- “Doctor Knows Best” or in Ben’s case- “Dr Ben Goldacre Knows Best”. He claims to want to translate the complexities of clinical trials, outcome switching, and the science behind the drugs we take, for the layperson to understand, but when the layperson challenges him, he calls them ‘angry, smeary conspiracy theorists” and then he refused to engage.

It seems to me that Ben is open to debate, as long as that debate has an outcome which is favorable to him.

On the one hand he brings up Seroxat study 329 as a paradigm of a bad clinical trial, and he tells us that there are thousands of similar examples across medicine which undermines the data, the trials, and the drugs we take, but on the other he wants us to fully trust and believe in medicine, and the science and evidence base behind it. He wants us to believe fully in evidence based medicine- all the while telling us that his entire crusade is based upon informing us that we cannot trust it!

In the section below, (taken from from the Seroxat Secrets Website in 2012), in his article: “The Drugs Don’t Work – A Modern Medical Scandal – By Dr Ben Goldacre“- Ben outlines why we can’t trust drug companies like GSK, yet in 2013, he tells us that GSK CEO Andrew Witty is a ‘good guy’, and that he’s ‘nice’ and he welcomes GSK on-board his Alltrials campaign with open arms, tweeting like an excited school boy, and doing ‘cartwheels’ etc. This despite GSK paying 3 Billion in fraud fines in the US the year before, and a half a million fine in a China bribe scandal in 2014, and ongoing investigations globally by the Serious Fraud Office etc.

I’ve done several posts already about this outrageous carry on, so I won’t repeat myself, apart from saying that- GSK can’t buy the kind of PR that Ben Goldacre provides for them, and as a patient damaged from a drug (Seroxat) because of (deliberate) misinformed consent by GSK- Ben licking up to the CEO of the company that destroyed my twenties- kinda makes me nauseous.

I would like to remind Ben, why Seroxat is so important, and why Study 329 and the behavior of GSK in regards to the whole Paxil/Seroxat debacle leaves a very bitter taste indeed, particularly when you have been damaged by it.

The Justice department excerpt below illustrates the seriousness of it, however the real world affects are what matter to me. Up to 2 million under-18’s (in the US alone) were prescribed a drug that they should never have been given. This was all on the basis of (illegal) off-label promotion, and many Paxil prescriptions were pushed on the backs of Study 329 (which was cited hundreds of times). How many of these young people went on to kill themselves Ben? Why don’t you ask Andrew Witty does he have stats on that? How many went on to self harm? How many had debilitating withdrawls (that GSK played down).

Paxil: In the criminal information, the government alleges that, from April 1998 to August 2003, GSK unlawfully promoted Paxil for treating depression in patients under age 18, even though the FDA has never approved it for pediatric use.

The United States alleges that, among other things, GSK participated in preparing, publishing and distributing a misleading medical journal article that misreported that a clinical trial of Paxil demonstrated efficacy in the treatment of depression in patients under age 18, when the study failed to demonstrate efficacy. At the same time, the United States alleges, GSK did not make available data from two other studies in which Paxil also failed to demonstrate efficacy in treating depression in patients under 18. The United States further alleges that GSK sponsored dinner programs, lunch programs, spa programs and similar activities to promote the use of Paxil in children and adolescents. GSK paid a speaker to talk to an audience of doctors and paid for the meal or spa treatment for the doctors who attended. Since 2004, Paxil, like other antidepressants, included on its label a “black box warning” stating that antidepressants may increase the risk of suicidal thinking and behavior in short-term studies in patients under age 18. GSK agreed to plead guilty to misbranding Paxil in that its labeling was false and misleading regarding the use of Paxil for patients under 18.

Also, Ben, you can ask Andrew Witty the next time you see him, if Seroxat is so unsafe for under-18’s, then how is it safe in the adult population? Ask him about the healthy volunteer studies on Seroxat Ben (done inside the company)? Ask him about that?

You’ll soon see that he’s likely not the nice guy that you believe he is if you start to ask him some questions about things like that I assure you…

The article below is from Ben. It was published in 2012 (before the Ben Goldacre/Alltrials/GSK love fest) and considering Ben’s praise for GSK nowadays, you could be forgiven for thinking that it was written by an entirely different person. It is scathingly critical of GSK, particularly in regards to Paroxetine (Seroxat/Paxil) and Avandia, but you don’t see this kind of stuff about GSK from Ben nowadays, he’s far too busy basking in his Alltrials GSK coup-glory to be critical it seems..

What a shame..

and how very dissappointing…

The Drugs Don’t Work – A Modern Medical Scandal – By Dr Ben Goldacre

The doctors prescribing the drugs don’t know they don’t do what they’re meant to. Nor do their patients. The manufacturers know full well, but they’re not telling. Drugs are tested by their manufacturers, in poorly designed trials, on hopelessly small numbers of weird, unrepresentative patients, and analysed using techniques that exaggerate the benefits.

Reboxetine is a drug I have prescribed. Other drugs had done nothing for my patient, so we wanted to try something new. I’d read the trial data before I wrote the prescription, and found only well-designed, fair tests, with overwhelmingly positive results. Reboxetine was better than a placebo, and as good as any other antidepressant in head-to-head comparisons. It’s approved for use by the Medicines and Healthcare products Regulatory Agency (the MHRA), which governs all drugs in the UK. Millions of doses are prescribed every year, around the world. Reboxetine was clearly a safe and effective treatment. The patient and I discussed the evidence briefly, and agreed it was the right treatment to try next. I signed a prescription.

But we had both been misled. In October 2010, a group of researchers was finally able to bring together all the data that had ever been collected on reboxetine, both from trials that were published and from those that had never appeared in academic papers. When all this trial data was put together, it produced a shocking picture. Seven trials had been conducted comparing reboxetine against a placebo. Only one, conducted in 254 patients, had a neat, positive result, and that one was published in an academic journal, for doctors and researchers to read. But six more trials were conducted, in almost 10 times as many patients. All of them showed that reboxetine was no better than a dummy sugar pill. None of these trials was published. I had no idea they existed.

It got worse. The trials comparing reboxetine against other drugs showed exactly the same picture: three small studies, 507 patients in total, showed that reboxetine was just as good as any other drug. They were all published. But 1,657 patients’ worth of data was left unpublished, and this unpublished data showed that patients on reboxetine did worse than those on other drugs. If all this wasn’t bad enough, there was also the side-effects data. The drug looked fine in the trials that appeared in the academic literature; but when we saw the unpublished studies, it turned out that patients were more likely to have side-effects, more likely to drop out of taking the drug and more likely to withdraw from the trial because of side-effects, if they were taking reboxetine rather than one of its competitors.

I did everything a doctor is supposed to do. I read all the papers, I critically appraised them, I understood them, I discussed them with the patient and we made a decision together, based on the evidence. In the published data, reboxetine was a safe and effective drug. In reality, it was no better than a sugar pill and, worse, it does more harm than good. As a doctor, I did something that, on the balance of all the evidence, harmed my patient, simply because unflattering data was left unpublished.

Nobody broke any law in that situation, reboxetine is still on the market and the system that allowed all this to happen is still in play, for all drugs, in all countries in the world. Negative data goes missing, for all treatments, in all areas of science. The regulators and professional bodies we would reasonably expect to stamp out such practices have failed us. These problems have been protected from public scrutiny because they’re too complex to capture in a soundbite. This is why they’ve gone unfixed by politicians, at least to some extent; but it’s also why it takes detail to explain. The people you should have been able to trust to fix these problems have failed you, and because you have to understand a problem properly in order to fix it, there are some things you need to know.

Drugs are tested by the people who manufacture them, in poorly designed trials, on hopelessly small numbers of weird, unrepresentative patients, and analysed using techniques that are flawed by design, in such a way that they exaggerate the benefits of treatments. Unsurprisingly, these trials tend to produce results that favour the manufacturer. When trials throw up results that companies don’t like, they are perfectly entitled to hide them from doctors and patients, so we only ever see a distorted picture of any drug’s true effects. Regulators see most of the trial data, but only from early on in a drug’s life, and even then they don’t give this data to doctors or patients, or even to other parts of government. This distorted evidence is then communicated and applied in a distorted fashion.

In their 40 years of practice after leaving medical school, doctors hear about what works ad hoc, from sales reps, colleagues and journals. But those colleagues can be in the pay of drug companies – often undisclosed – and the journals are, too. And so are the patient groups. And finally, academic papers, which everyone thinks of as objective, are often covertly planned and written by people who work directly for the companies, without disclosure. Sometimes whole academic journals are owned outright by one drug company. Aside from all this, for several of the most important and enduring problems in medicine, we have no idea what the best treatment is, because it’s not in anyone’s financial interest to conduct any trials at all.

Now, on to the details.

In 2010, researchers from Harvard and Toronto found all the trials looking at five major classes of drug – antidepressants, ulcer drugs and so on – then measured two key features: were they positive, and were they funded by industry? They found more than 500 trials in total: 85% of the industry-funded studies were positive, but only 50% of the government-funded trials were. In 2007, researchers looked at every published trial that set out to explore the benefits of a statin. These cholesterol-lowering drugs reduce your risk of having a heart attack and are prescribed in very large quantities. This study found 192 trials in total, either comparing one statin against another, or comparing a statin against a different kind of treatment. They found that industry-funded trials were 20 times more likely to give results favouring the test drug.

These are frightening results, but they come from individual studies. So let’s consider systematic reviews into this area. In 2003, two were published. They took all the studies ever published that looked at whether industry funding is associated with pro-industry results, and both found that industry-funded trials were, overall, about four times more likely to report positive results. A further review in 2007 looked at the new studies in the intervening four years: it found 20 more pieces of work, and all but two showed that industry-sponsored trials were more likely to report flattering results.

It turns out that this pattern persists even when you move away from published academic papers and look instead at trial reports from academic conferences. James Fries and Eswar Krishnan, at the Stanford University School of Medicine in California, studied all the research abstracts presented at the 2001 American College of Rheumatology meetings which reported any kind of trial and acknowledged industry sponsorship, in order to find out what proportion had results that favoured the sponsor’s drug.

In general, the results section of an academic paper is extensive: the raw numbers are given for each outcome, and for each possible causal factor, but not just as raw figures. The “ranges” are given, subgroups are explored, statistical tests conducted, and each detail is described in table form, and in shorter narrative form in the text. This lengthy process is usually spread over several pages. In Fries and Krishnan (2004), this level of detail was unnecessary. The results section is a single, simple and – I like to imagine – fairly passive-aggressive sentence:

“The results from every randomised controlled trial (45 out of 45) favoured the drug of the sponsor.”

How does this happen? How do industry-sponsored trials almost always manage to get a positive result? Sometimes trials are flawed by design. You can compare your new drug with something you know to be rubbish – an existing drug at an inadequate dose, perhaps, or a placebo sugar pill that does almost nothing. You can choose your patients very carefully, so they are more likely to get better on your treatment. You can peek at the results halfway through, and stop your trial early if they look good. But after all these methodological quirks comes one very simple insult to the integrity of the data. Sometimes, drug companies conduct lots of trials, and when they see that the results are unflattering, they simply fail to publish them.

Because researchers are free to bury any result they please, patients are exposed to harm on a staggering scale throughout the whole of medicine. Doctors can have no idea about the true effects of the treatments they give. Does this drug really work best, or have I simply been deprived of half the data? No one can tell. Is this expensive drug worth the money, or has the data simply been massaged? No one can tell. Will this drug kill patients? Is there any evidence that it’s dangerous? No one can tell. This is a bizarre situation to arise in medicine, a discipline in which everything is supposed to be based on evidence.

And this data is withheld from everyone in medicine, from top to bottom. Nice, for example, is the National Institute for Health and Clinical Excellence, created by the British government to conduct careful, unbiased summaries of all the evidence on new treatments. It is unable either to identify or to access data on a drug’s effectiveness that’s been withheld by researchers or companies: Nice has no more legal right to that data than you or I do, even though it is making decisions about effectiveness, and cost-effectiveness, on behalf of the NHS, for millions of people.

In any sensible world, when researchers are conducting trials on a new tablet for a drug company, for example, we’d expect universal contracts, making it clear that all researchers are obliged to publish their results, and that industry sponsors – which have a huge interest in positive results – must have no control over the data. But, despite everything we know about industry-funded research being systematically biased, this does not happen. In fact, the opposite is true: it is entirely normal for researchers and academics conducting industry-funded trials to sign contracts subjecting them to gagging clauses that forbid them to publish, discuss or analyse data from their trials without the permission of the funder.

This is such a secretive and shameful situation that even trying to document it in public can be a fraught business. In 2006, a paper was published in the Journal of the American Medical Association (Jama), one of the biggest medical journals in the world, describing how common it was for researchers doing industry-funded trials to have these kinds of constraints placed on their right to publish the results. The study was conducted by the Nordic Cochrane Centre and it looked at all the trials given approval to go ahead in Copenhagen and Frederiksberg. (If you’re wondering why these two cities were chosen, it was simply a matter of practicality: the researchers applied elsewhere without success, and were specifically refused access to data in the UK.) These trials were overwhelmingly sponsored by the pharmaceutical industry (98%) and the rules governing the management of the results tell a story that walks the now familiar line between frightening and absurd.

For 16 of the 44 trials, the sponsoring company got to see the data as it accumulated, and in a further 16 it had the right to stop the trial at any time, for any reason. This means that a company can see if a trial is going against it, and can interfere as it progresses, distorting the results. Even if the study was allowed to finish, the data could still be suppressed: there were constraints on publication rights in 40 of the 44 trials, and in half of them the contracts specifically stated that the sponsor either owned the data outright (what about the patients, you might say?), or needed to approve the final publication, or both. None of these restrictions was mentioned in any of the published papers.

When the paper describing this situation was published in Jama, Lif, the Danish pharmaceutical industry association, responded by announcing, in the Journal of the Danish Medical Association, that it was “both shaken and enraged about the criticism, that could not be recognised”. It demanded an investigation of the scientists, though it failed to say by whom or of what. Lif then wrote to the Danish Committee on Scientific Dishonesty, accusing the Cochrane researchers of scientific misconduct. We can’t see the letter, but the researchers say the allegations were extremely serious – they were accused of deliberately distorting the data – but vague, and without documents or evidence to back them up.

Nonetheless, the investigation went on for a year. Peter Gøtzsche, director of the Cochrane Centre, told the British Medical Journal that only Lif’s third letter, 10 months into this process, made specific allegations that could be investigated by the committee. Two months after that, the charges were dismissed. The Cochrane researchers had done nothing wrong. But before they were cleared, Lif copied the letters alleging scientific dishonesty to the hospital where four of them worked, and to the management organisation running that hospital, and sent similar letters to the Danish medical association, the ministry of health, the ministry of science and so on. Gøtzsche and his colleagues felt “intimidated and harassed” by Lif’s behaviour. Lif continued to insist that the researchers were guilty of misconduct even after the investigation was completed.

Paroxetine is a commonly used antidepressant, from the class of drugs known as selective serotonin reuptake inhibitors or SSRIs. It’s also a good example of how companies have exploited our long-standing permissiveness about missing trials, and found loopholes in our inadequate regulations on trial disclosure.

To understand why, we first need to go through a quirk of the licensing process. Drugs do not simply come on to the market for use in all medical conditions: for any specific use of any drug, in any specific disease, you need a separate marketing authorisation. So a drug might be licensed to treat ovarian cancer, for example, but not breast cancer. That doesn’t mean the drug doesn’t work in breast cancer. There might well be some evidence that it’s great for treating that disease, too, but maybe the company hasn’t gone to the trouble and expense of getting a formal marketing authorisation for that specific use. Doctors can still go ahead and prescribe it for breast cancer, if they want, because the drug is available for prescription, it probably works, and there are boxes of it sitting in pharmacies waiting to go out. In this situation, the doctor will be prescribing the drug legally, but “off-label”.

Now, it turns out that the use of a drug in children is treated as a separate marketing authorisation from its use in adults. This makes sense in many cases, because children can respond to drugs in very different ways and so research needs to be done in children separately. But getting a licence for a specific use is an arduous business, requiring lots of paperwork and some specific studies. Often, this will be so expensive that companies will not bother to get a licence specifically to market a drug for use in children, because that market is usually much smaller.

So it is not unusual for a drug to be licensed for use in adults but then prescribed for children. Regulators have recognised that this is a problem, so recently they have started to offer incentives for companies to conduct more research and formally seek these licences.

When GlaxoSmithKline applied for a marketing authorisation in children for paroxetine, an extraordinary situation came to light, triggering the longest investigation in the history of UK drugs regulation. Between 1994 and 2002, GSK conducted nine trials of paroxetine in children. The first two failed to show any benefit, but the company made no attempt to inform anyone of this by changing the “drug label” that is sent to all doctors and patients. In fact, after these trials were completed, an internal company management document stated: “It would be commercially unacceptable to include a statement that efficacy had not been demonstrated, as this would undermine the profile of paroxetine.” In the year after this secret internal memo, 32,000 prescriptions were issued to children for paroxetine in the UK alone: so, while the company knew the drug didn’t work in children, it was in no hurry to tell doctors that, despite knowing that large numbers of children were taking it. More trials were conducted over the coming years – nine in total – and none showed that the drug was effective at treating depression in children.

It gets much worse than that. These children weren’t simply receiving a drug that the company knew to be ineffective for them; they were also being exposed to side-effects. This should be self-evident, since any effective treatment will have some side-effects, and doctors factor this in, alongside the benefits (which in this case were nonexistent). But nobody knew how bad these side-effects were, because the company didn’t tell doctors, or patients, or even the regulator about the worrying safety data from its trials. This was because of a loophole: you have to tell the regulator only about side-effects reported in studies looking at the specific uses for which the drug has a marketing authorisation. Because the use of paroxetine in children was “off-label”, GSK had no legal obligation to tell anyone about what it had found.

People had worried for a long time that paroxetine might increase the risk of suicide, though that is quite a difficult side-effect to detect in an antidepressant. In February 2003, GSK spontaneously sent the MHRA a package of information on the risk of suicide on paroxetine, containing some analyses done in 2002 from adverse-event data in trials the company had held, going back a decade. This analysis showed that there was no increased risk of suicide. But it was misleading: although it was unclear at the time, data from trials in children had been mixed in with data from trials in adults, which had vastly greater numbers of participants. As a result, any sign of increased suicide risk among children on paroxetine had been completely diluted away.

Later in 2003, GSK had a meeting with the MHRA to discuss another issue involving paroxetine. At the end of this meeting, the GSK representatives gave out a briefing document, explaining that the company was planning to apply later that year for a specific marketing authorisation to use paroxetine in children. They mentioned, while handing out the document, that the MHRA might wish to bear in mind a safety concern the company had noted: an increased risk of suicide among children with depression who received paroxetine, compared with those on dummy placebo pills.

This was vitally important side-effect data, being presented, after an astonishing delay, casually, through an entirely inappropriate and unofficial channel. Although the data was given to completely the wrong team, the MHRA staff present at this meeting had the wit to spot that this was an important new problem. A flurry of activity followed: analyses were done, and within one month a letter was sent to all doctors advising them not to prescribe paroxetine to patients under the age of 18.

How is it possible that our systems for getting data from companies are so poor, they can simply withhold vitally important information showing that a drug is not only ineffective, but actively dangerous? Because the regulations contain ridiculous loopholes, and it’s dismal to see how GSK cheerfully exploited them: when the investigation was published in 2008, it concluded that what the company had done – withholding important data about safety and effectiveness that doctors and patients clearly needed to see – was plainly unethical, and put children around the world at risk; but our laws are so weak that GSK could not be charged with any crime.

After this episode, the MHRA and EU changed some of their regulations, though not adequately. They created an obligation for companies to hand over safety data for uses of a drug outside its marketing authorisation; but ridiculously, for example, trials conducted outside the EU were still exempt. Some of the trials GSK conducted were published in part, but that is obviously not enough: we already know that if we see only a biased sample of the data, we are misled. But we also need all the data for the more simple reason that we need lots of data: safety signals are often weak, subtle and difficult to detect. In the case of paroxetine, the dangers became apparent only when the adverse events from all of the trials were pooled and analysed together.

That leads us to the second obvious flaw in the current system: the results of these trials are given in secret to the regulator, which then sits and quietly makes a decision. This is the opposite of science, which is reliable only because everyone shows their working, explains how they know that something is effective or safe, shares their methods and results, and allows others to decide if they agree with the way in which the data was processed and analysed. Yet for the safety and efficacy of drugs, we allow it to happen behind closed doors, because drug companies have decided that they want to share their trial results discretely with the regulators. So the most important job in evidence-based medicine is carried out alone and in secret. And regulators are not infallible, as we shall see.

Rosiglitazone was first marketed in 1999. In that first year, Dr John Buse from the University of North Carolina discussed an increased risk of heart problems at a pair of academic meetings. The drug’s manufacturer, GSK, made direct contact in an attempt to silence him, then moved on to his head of department. Buse felt pressured to sign various legal documents. To cut a long story short, after wading through documents for several months, in 2007 the US Senate committee on finance released a report describing the treatment of Buse as “intimidation”.

But we are more concerned with the safety and efficacy data. In 2003 the Uppsala drug monitoring group of the World Health Organisation contacted GSK about an unusually large number of spontaneous reports associating rosiglitazone with heart problems. GSK conducted two internal meta-analyses of its own data on this, in 2005 and 2006. These showed that the risk was real, but although both GSK and the FDA had these results, neither made any public statement about them, and they were not published until 2008.

During this delay, vast numbers of patients were exposed to the drug, but doctors and patients learned about this serious problem only in 2007, when cardiologist Professor Steve Nissen and colleagues published a landmark meta-analysis. This showed a 43% increase in the risk of heart problems in patients on rosiglitazone. Since people with diabetes are already at increased risk of heart problems, and the whole point of treating diabetes is to reduce this risk, that finding was big potatoes. Nissen’s findings were confirmed in later work, and in 2010 the drug was either taken off the market or restricted, all around the world.

Now, my argument is not that this drug should have been banned sooner because, as perverse as it sounds, doctors do often need inferior drugs for use as a last resort. For example, a patient may develop idiosyncratic side-effects on the most effective pills and be unable to take them any longer. Once this has happened, it may be worth trying a less effective drug if it is at least better than nothing.

The concern is that these discussions happened with the data locked behind closed doors, visible only to regulators. In fact, Nissen’s analysis could only be done at all because of a very unusual court judgment. In 2004, when GSK was caught out withholding data showing evidence of serious side-effects from paroxetine in children, their bad behaviour resulted in a US court case over allegations of fraud, the settlement of which, alongside a significant payout, required GSK to commit to posting clinical trial results on a public website.

Nissen used the rosiglitazone data, when it became available, and found worrying signs of harm, which they then published to doctors – something the regulators had never done, despite having the information years earlier. If this information had all been freely available from the start, regulators might have felt a little more anxious about their decisions but, crucially, doctors and patients could have disagreed with them and made informed choices. This is why we need wider access to all trial reports, for all medicines.

Missing data poisons the well for everybody. If proper trials are never done, if trials with negative results are withheld, then we simply cannot know the true effects of the treatments we use. Evidence in medicine is not an abstract academic preoccupation. When we are fed bad data, we make the wrong decisions, inflicting unnecessary pain and suffering, and death, on people just like us.

Pysch drug link to violent episodes analysed

105

Friday, May 20, 2016

Jennifer Hough

Forensic testing of blood can now determine if anti- depressants were the cause of violent behaviour, including murder or suicide, new research has found.

Genetic variations in metabolism affect how different people react to anti-depressants, and now medical examiners say they can identify those variations, and use the evidence to “potentially absolve people charged with homicide”, and explain why they acted like they did.

The research, published recently in the Journal of Forensic and Legal Medicine, was carried out by a medical specialist, a forensic psychiatrist and a pharmacogeneticist. It looks specifically at three cases where people with no previous diagnosis, who were prescribed antidepressants for stress-related issues, ended up killing others, with two attempting suicide.

“An out-of-character unmotivated homicide or suicide by a person taking medication might be chemically induced and involuntary. The capacity to use frontal lobe functions and control behaviour can be impaired by brain toxicity,” the paper states.

“None improved on medication, and no prescriber recognised complaints as adverse drug reactions or was aware of impending danger.”

The researchers took accounts of restlessness, akathisia (a state of severe restlessness associated with thoughts of death and violence), confusion, delirium, euphoria, extreme anxiety, obsessive preoccupation with aggression, and incomplete recall of events.

“Weird impulses to kill were acted on without warning. On recovery, all recognised their actions to be out of character, and their beliefs and behaviours horrified them,” the paper notes.

The research concludes that the “medicalisation of common human distress” has resulted in a very large number of people getting medication that may do more harm than good by causing “suicides and homicides and the mental states that lead up to them”.

Irish mental health campaigner Leonie Fennell, whose son Shane was prescribed anti-depressants and soon afterwards killed himself and another person, said she has been aware of this evolving science for some years, and has had Shane’s blood tested in Australia.

The researcher who tested Shane’s blood, Dr Yolande Lucire, is one of the papers’ authors. She cited his case in another research project she carried out in 2011. Dr Lucire noted Shane was initially prescribed a double dose of the common SSRI anti-depressant, citalopram.

Five days later he overdosed on the tablets, and two days later he told his doctor, who then restarted him on a lower dose of the anti-depressant.

“He immediately became violently akathisic, unable to stay in one place, moving constantly between the houses of friends, unable to sit and have a conversation. According to his mother, communicating with him was like ‘talking to a brick wall’. His friends reported that, immediately after taking citalopram, he became agitated, emotional, irrational, and aggressive. His brother saw him throw a mobile phone, destroying it, with trivial, if any provocation,” Lucire writes.

Post-mortem toxicology of blood revealed levels of citalopram of about 30 times the therapeutic level.

Dr Lucire, a forensic psychiatrist who specialises in adverse drug reactions to psychiatric drugs, said in her experience patients do not need the drugs they are being prescribed.

THE mother of student Shane Clancy, who stabbed a young man to death before taking his own life, has called for an independent inquiry into the effect anti-depressant drugs had upon her son.

Leonie Fennell explained her decision to participate in a TV3 documentary aired last night, which looked at the events surrounding the death of her son Shane and Sebastian Creane (22), who was fatally stabbed in August 2009.

After buying a set of knives, Shane had driven to Bray where he stabbed Sebastian to death. He then stabbed his ex-girlfriend Jennifer Hannigan, before stabbing Sebastian’s brother Dylan and proceeding to take his own life.

Shane’s body was found at the rear of the Creane home in Bray with a number of self-inflicted knife wounds. Shane had been depressed in the weeks before the tragedy and had been on medication. His mother has since campaigned for greater controls surrounding anti-depressant drugs known as selective serotonin reuptake inhibitors (SSRIs)

Ms Fennell said: “We decided to participate in this programme because it provided others with the opportunity to hear about the role that SSRI antidepressants played in the tragic deaths.

“This is information we wish we had known before Shane’s death and which we believe may prevent other families suffering the pain we all now live with.”

In a blog written before the programme was aired, she said: “Our over-riding feeling, from the very beginning, has been that if this can happen to Shane it could happen to anyone.”

Tuesday, March 11, 2014

FRom Seroxat Sufferers

A Search for Justice – Death in Bray – Review

To write an opinion piece without offending is always going to be tricky. In the past I have wrote many articles where I have never really given any thought to my opinions hurting anyone because, in the main, I write about pharmaceutical companies, medicine regulators and psychiatrists whom I don’t really care much for.

This piece is different as it concerns a number of people who are all suffering loss, all, who I mention, in the following piece, are searching for answers. We have a bunch of people divided by opinion which makes it increasingly difficult for any of the parties to accept facts.

My opinion, it will be argued, is one of bias – I cannot refute this but can offer my reasons for sitting on one side of the fence opposed to sitting on the other side or, indeed, sitting on the actual fence.

Last night TV3, an Irish network channel, aired a 90 minute special that covered the death of 22 year-old Sebastian Creane. The documentary, ‘A Search for Justice – Death in Bray’, has, if anything, raised some questions that need answering.

Before I go on I would just like to stipulate that I did not know Sebastian Creane nor Shane Clancy. I have, since this tragic incident, met with Shane Clancy’s mother, partner and family on numerous occasions and they, like other families I have met and wrote about, have become good friends.

So, many may think that my bias will originate from this friendship. I can state clearly that this is not the case.

It was my father who, many years ago, said to me, “Always write about the things you know about”, which is something that I have tried to do. As a writer my job is similar to the programme-makers of ‘A Search for Justice – Death in Bray’ in as much that I wish to raise certain concerns and my ultimate wish is that those concerns are debated.

Watching the documentary was difficult as many people have been affected by the tragedy it covered, none more so than the parents of Sebastian Creane and Shane Clancy.

Sebastian Creane, 22, was stabbed to death on August 16, 2009, by Shane Clancy, 22, who then killed himself at the Creane family home in Bray. A subsequent inquest into the alleged suicide of Clancy resulted in a coroner’s decision, based on evidence given, of an “open verdict”.

This, it seemed, was the basis of ‘A Search for Justice – Death in Bray’.

Sebastian Creane parents, Nuala and Jay, were not happy with the outcome of the Shane Clancy inquest and both they and friends of Sebastian took umbrage to Leonie and her partner, Tony, appearing on The Late Late Show [RTE] some 6 weeks after the tragic incident.

If I were a neutral watching ‘A Search for Justice – Death in Bray’ I would have been of the opinion that Shane Clancy was a crazed young man who killed his former girlfriend’s lover and then, after realisation of his actions, decided to take his own life rather than face the consequences of those actions. I believe the documentary, although compelling, didn’t really delve into the evidence of antidepressant homicide/suicide.

I have been writing and researching about the side-effects of SSRi medications for almost nine years now and this case is not too dissimilar to other cases of bizarre beahviour from those who have ingested these powerful group of drugs.

Homicide Vs Suicide – What is the difference?

Homicide is the act of killing another.

Suicide is the act of killing oneself.

So, why did the coroner in Shane Clancy’s inquest deliver an “open verdict”?

Well, based upon all evidences provided to the inquest it could not be deemed that Shane Clancy knew that he was killing himself [suicide]. The reasons why he never knew this have never been elaborated on [officially].

If Shane never knew he was about to kill himself then did he know that he was carrying out an act of homicide when he killed Sebastian?

This, of course, was never answered. Shane’s inquest was not about finding fault or laying the finger of blame, it was, as all inquests are, about preventing any future deaths in the manner of how Shane Clancy died.

A very important issue was raised in the documentary. If Shane had not killed himself after killing Sebastian [and attacking others] then he would have been tried and [more than likely] convicted. I say more than likely because it is very rare for accused killers or criminals to be acquitted by using induced psychosis as a result of medication being taken. Rare but not unheard of.

In February 24, 2000 Connecticut Superior Court Judge J. Arnold acquitted Christopher DeAngelo of first-degree robbery on the grounds that the defendant lacked substantial capacity as a result of mental disease or defect. The judge specifically attributed Mr. DeAngelo’s impaired state to his prescribed Xanax and Prozac.[1]

David Crespi plead guilty to brutally stabbing his five-year-old twin daughters to death, but there is one person that still believes he’s innocent: their mother.

Kimberly Crespi has fought for her husband from the beginning, forgiving him for his horrific crime in 2006 and now she wants to share their story with the world.

Mrs Crespi believes Crespi killed their girls because he was misdiagnosed with a personality disorder and put on a cocktail of drugs which in turn, caused a psychotic episode. [2]

Clinical psychologist, Dr. David Antonuccio, was one of multiple doctors who gave Charles Baymiller a mental evaluation. He said that she was displaying negative drug side effects prior to the killing such as agitation and sleep deprivation and had visited her doctor to address them. Instead, a nurse practitioner increased her dosages. He said that was not an appropriate adjustment. Antonuccio said that within weeks, the drugs could have caused her to be in a drug-induced state, where she would be in a “fog-like, sleepwalking” state and later have no memory of her actions. He said the known side effects of Paxil are irritability, aggessiveness and suicidal tendencies.” [3]

Probably the most infamous of all is the case of Donald Schell. Here’s the verdict of the jury [Fig 1]

These are just four incidents, there are many more if one researches.

Irish psychiatrist, Patricia Casey, who appeared in the TV3 special, claimed that there is no evidence to suggest that the SSRi group of drugs can cause homicide. Some of the instances above, may be debated but, nonetheless, they show evidence that Casey claims does not exist.

Back in 2011 Lawyers representing Patricia Casey wrote to the mother of Shane Clancy. Casey took umbrage to a blog post and subsequent comments that appeared on the Leonie Fennell blog. Fennell was, in essence, told to remove the comments or face being sued by Casey. Back stories here and here.

Casey was interviewed and appeared in the 90 minute special last night, she made assertions that Shane Clancy had a “psychiatric illness” and did not believe his actions were due to citalopram he was taking. [Whilst alive Shane was seen by three professionals, none of whom diagnosed him with a psychiatric illness]

From what I can gather, Casey has based her diagnosis around reading documents from the case and reviewing CCTV footage of Shane Clancy on the night of the tragedy. She is, like many in this case, offering her own opinion. Casey, and her supporters, will argue that she is in a position to offer such evidence because she is a professional psychiatrist. End of the day Casey has offered an opinion that cannot be backed up with any scientific facts. She cannot prove, one way or the other, that her diagnosis of Shane Clancy is correct.

Casey also touched upon her links to the pharmaceutical company Lundbeck in last night’s documentary. Lundbeck manufacture the antidepressant that Shane Clancy was prescribed.

Shane’s mother, Leonie Fennell, had, back in 2011, highlighted a possible conflict of interest between Casey and Lundbeck [here]

Not only does Casey not believe that citalopram may have been the cause of Shane Clancy’s out of character behaviour, she also believes that antidepressants do not cause suicide. [4] Something that, I believe, is an appalling and dangerous statement given the warnings placed on the packets of SSRi’s such as citalopram.

The family and friends of Sebastian Creane and Shane Clancy will always have to deal with their loss, it will never go away. Both parties will also battle with the many unanswered questions. All parties concerned will try to seek justice. On one side of the fence we have those that refuse to believe the evidence that SSRi medications can cause homicide and suicide – on the other we have parents who refuse to believe that their son could commit such a heinous crime.

On a personal front, and to add some weight to my argument, I became suicidal when withdrawing from another SSRi, namely GSK’s Seroxat. I also became aggressive and, totally out of character, went out one night seeking confrontation. The area I chose was a country park in Birmingham. I wanted violence and I didn’t much care about the consequences of my actions if I would have had my thirst for violence quenched. [5] Luckily, there was nobody walking through the darkened country park during the early hours of that particular morning. Had they have been then I, myself, may have been the subject of much debate and maybe Casey, or any other psychiatrist for that matter, may have been convinced that I had a chemical imbalance in my brain that made me mentally ill.

In truth, I was prescribed Seroxat for “work-related stress”

Shane Clancy was prescribed citalopram because he was dealing with matters of the heart, a relationship split with his girlfriend.

I don’t think for one minute that either of us were mentally ill.

Airing a documentary on such a subject was a brave move by TV3. It was very brave of Leonie Fennell, Nuala, Jay and Dylan Creane and Jennifer Hannigan to appear in front of TV camera’s, by doing so they have people talking, writing, debating, insinuating. No statements, as far as I am aware were given to the programme-makers by H. Lundbeck A/S. I find this quite astonishing given that in one of their own citalopram studies 14 patients taking citalopram attempted suicide or reported suicidal ideation compared with 5 patients taking placebo,” [6]

As always, my thoughts are with both parties here. I cannot imagine what it must feel like to lose a child, particularly in such circumstances. I sincerely hope that one day the truth will out and that those left to pick up the pieces will one day be able to embrace that truth and find the minutest bit of comfort from it.

A Search for Justice – Death in Bray

I have already expressed my opinion on the Shane Clancy murder/suicide and those views can be found here. No doubt much opinion and debate will follow after this documentary airs on TV3 tonight. In the meantime, some readers might be interested in this article by Maria Bradshaw, mother of Toran Henry. Like Shane, Toran also died by SSRI induced suicide. Maria is a fantastic patient advocate, she is extremely well informed, and she expresses her views on the subject of SSRI’s and the related issues very well.

I think Professor Patricia Casey has behaved unethically and brought the profession of psychiatry into disrepute in a statement she made in the media today diagnosing a man who died nearly five years ago as mentally ill.

This is my opinion. It is based on never having met Prof Casey, never having met anyone who knows her well, never having seen her contract with Lundbeck Pharmaceuticals or attended any of the paid services she has delivered for them. It is based on my not having expert knowledge of the Code of Ethics of the Irish College of psychiatry or seen any of Prof Casey’s notes in relation to diagnosing the dead. It could therefore be seen as an uninformed opinion by someone who thinks they have the right to comment because they have an MBA, have dealt with issues of conflicts of interest and business ethics in their work and has been influenced by those who consider they have been harmed by the Professor.

Professor Patricia Casey would no doubt be outraged by my assuming to voice an opinion about what motivates her actions and making an assessment of her behaviour. She would quite reasonably argue I have insufficient evidence on which to base my views and that as such they have little or no validity or value. I imagine she would argue that publishing my opinion is disrespectful and contributes nothing worthwhile to any discussion of the ethical practice of psychiatry.

Where her credibility has been challenged in the past, Prof Casey has generally issued a solicitors letter requiring any published criticism be removed and the writer desist from publishing further criticism of her. I assume that should I question her motives and suggest they are influenced by her financial relationship with Lundbeck Pharmaceuticals, she would consider issuing me with the same.

On Monday night, Irish television is screening a documentary on the events leading to the deaths of Shane Clancy and Sebastian Creane. I have previously written a blog about Shane who, under the influence of Citalopram killed Sebastian and then himself. In today’s Sunday Times, Professor Patricia Casey is quoted as saying that she does not believe the drug played any role in Shane’s actions and that in her opinion he suffered from a psychiatric illness.

On what does Prof Casey base this opinion? Shane is dead and she did not ever meet him when he was alive. She has never spoken to his family, does not have access to his medical records and has not spoken to his doctor. By any analysis she has none of the requisite information on which to make a diagnosis. Not one shred. She has spoken to his ex-girlfriend and the family of the person he killed but despite the DSM-V lowering the diagnostic threshold for psychiatric disorders, even it does not allow for a diagnosis to be made solely on interviews with ex partners and the family of those the patient has harmed.

A recent study on the validity of psychological autopsy studies –post mortem psychiatric assessments – concluded that “as a diagnostic tool psychological autopsies should now be abandoned.” Conducting a mental state assessment on a dead person is problematic for a variety of reasons including whether it is really possible to assign psychiatric diagnoses to someone who is dead by interviewing someone else given that the majority of questions on which a diagnosis is based cannot be reliably answered by anyone other than the deceased, and cannot therefore lead to valid conclusions. I have written about this study here.

Shane’s medical file records his experiencing adverse effects from the drug Citalopram. It does not record any diagnosis of a mental disorder. His file records the information gathered by a doctor who actually sat in the same room as Shane.

Professor Casey’s offer to provide expert evidence at Shane’s inquest was declined by the Coroner. Professor David Healy who did provide expert testimony had access to Shane’s family and his medical records. He is both a psychiatrist and a psychopharmacologist. He is an acknowledged expert in the area of psychiatric drug induced suicide and homicide having conducted research on these issues and provided expert testimony in numerous homicide trials. He is the founder and CEO of a global pharmacovigilance organisation specializing in assessing causal relationships between drugs and adverse reactions. For these reasons, he was selected over Patricia Casey to provide evidence at the inquest examining the circumstances leading to Shane and Sebastian’s deaths. The Coroner’s decision in this respect should not be difficult to understand.

Despite having far more information than Professor Casey, Professor Healy did not presume to conduct a psychological autopsy on Shane. Rather he provided an expert opinion, using good science, on the causal link between Citalopram and Shane’s killing of someone else and himself. He is an expert in making such assessments. Professor Casey is not. Prof Healy provides evidence to support his assessment of the causal relationship between the drug and Shane’s actions. Professor Casey does not provide evidence to support her diagnosing of Shane as psychiatrically ill almost five years after his death.

Psychiatry is the one field of ‘medicine’ that has spawned a huge international survivors movement peopled by those who have suffered psychiatric abuse. The practice of conducting psychological autopsies is in my view another form of psychiatric abuse. Those of us whose children have died as a result of an acknowledged adverse reaction to psychiatric drugs are standing up for our rights – and theirs – not to be stigmatized with psychiatric labels following their deaths. We believe that psychological autopsies are unscientific and unethical. We know they are disrespectful and cause pain to families.

We demand that psychiatrists like Professor Casey cease and desist from this practice forthwith and we ask that the psychiatric survivors movement support the right of those who did not survive to cease being hounded and abused by psychiatry as they lie in their graves

Before I begin this blog post, I would like to offer my sincere condolences to all those affected by this, the loss must be unimaginable, for Sebastian Creane, his family, and to Jennifer Hannigan and her family, and of course to Leonie, for Shane, and Shane’s family. Many people have suffered in this. Many people have been affected. This is a terrible tragedy which is difficult for many to comprehend, and understandably so.

However, I sincerely believe that this tragedy would not have happened had Shane, or his family, been warned of the potential side effects of SSRI drugs. SSRI side effects such as Akathisa, agitation, anxiety, aggression, impulsivity, homicidal and suicidal ideation, are commonly reported from patients on SSRI’s. They are even written in the Patient information leaflets now (although that’s more to cover drug companies from lawsuits than a humane act on their part, and also hardly anyone looks at the PIL, particularly young people, therefore it’s close to useless).

I have had these side effects whilst on SSRI’s and I have talked to many others who have experienced them also. There is a massive culture of denial within mainstream psychiatry because it is a pandora’s box which- if opened- would destroy the credibility of psychiatric drugs. If psychiatric drugs are perceived as unsafe then this undermines psychiatry. The industry and psychiatry have a vested interest in keeping the public in the dark about this. I don’t just think this, it’s a fact, and it is well known by those of us involved in bringing the truth about these drugs to public consciousness.

These facts cannot bring back a loved one, but they are significant for trying to understand why tragedies like this occur. One brilliant website which has documented SSRI murder/suicides is AntiDepAware. What has been correlated here on this site is quite staggering, and in my opinion the evidence is irrefutable now. Shane’s case, is one of many, and anyone on an SSRI could end up in a similar situation, and the real tragedy is- the public are mostly completely unaware. These tragedies could have been avoided if people were adequately warned, but the pharmaceutical industry and psychiatry do not want to be held accountable, therefore they continue to deny. Furthermore, the profits on these drugs are obscene, and profit and money is the bottom line here.

On Monday the 10th of March, Irish channel TV3, will air a documentary about the Shane Clancy tragedy called: “A search for justice: death in Bray. I wrote about Shane when this tragic event happened (see here and here) and it might seem premature writing a post before this documentary airs but I feel before the media spin kicks in, it is appropriate, as many important aspects might get lost in the sensationalism which will inevitably follow.

The reason why I first wrote about Shane, and why I care about all this- is because -like Shane, I was prescribed an SSRI drug for depression (mine was Seroxat, Shane’s was Cipramil). I was also around Shane’s age when this happened. I was 21, and Shane was 22. It was also, like in Shane’s case- my mother who brought me to a psychiatrist and a GP initially- because she was desperate to help alleviate the sheer despair I was experiencing from crippling depression. Shane’s mother Leonie, did the same thing as my mother, (as any mother would) and like myself and my mother, Leonie and Shane were not warned of the possible dangerous side effects from SSRI drugs. Effectively, there was no informed consent. None of us were warned. This is appalling.

I will never forget the awful feeling in the first few days and weeks of taking Seroxat. I remember the swooshing, dizzying, giddy- unreality buzzing in my mind, as the chemical began to course through the blood into my brain. I went from being severely depressed, to severely out of my head. I would get these rushes and shivers, my eyes would roll and the world felt all lopsided. My teeth would clench, my jaw muscles would clench, and I’d get audio hallucinations during the day, and Stephen King style nightmares and sweats at night. If I stood up too quickly I would almost faint as my blood pressure was affected from the SSRI. I would stupor, and my eyes were like pinholes, I looked like a junkie. I would dribble on myself, as I sat numbed like a vegetable watching day time TV- as the levels of Seroxat accumulated, I felt more and more careless, more and more distant from me, my family and my surroundings. I became completely de-personalized.

It was undoubtedly a drugged up state, but not the kind of drugged up state which you would imagine these so called ‘happy pills’ to be. There was no happy-ness, no bliss, just a feeling of numbness, inhibition, blur and muddled confusion. A buzzy blur, an incoherency of thoughts and feelings all day, everything just out of whack and out of sync. As the weeks and months went on, and the Seroxat pills went down, I began to feel aggressive, particularly towards my family, I would snap at them and often they were afraid of me, or afraid of what the drug was doing to me, what I was becoming. The night sweats and nightmares turned into night spasms and horrifically violent dreams which scared the hell out me. I would wake up terrified, horrified that my mind could conjure up scenes of such horrible violence and mayhem. On a few occasions in the first few months on Seroxat I lashed out at my mother and my sister, and at one point I chased my father around his house, with every intention of attacking him. He rang the police and I left, like a possessed madman, slamming his door and shattering the glass. This aggression was completely and utterly out of character for me, I am the most passive, non confrontational person in the world. I have no doubt it was the effects of the SSRI. No doubts at all. SSRI’s can push some people over the edge. The creators of this website (SSRI stories) have collected 5000 media examples of SSRI suicides, homicides, rage etc. That, is likely- the tip of the iceberg.

Since coming off Seroxat over 10 years ago, I have sought to inform and educate others and make them aware of the dangers of SSRI medications. I have spoken to others who have experienced the same effects. I have met government ministers, journalists, psychiatrists, educators, activists, the gamut of professions. I have tried my best to get the truth out there about Seroxat and SSRI’s. These drugs can be very dangerous for some people. It’s like Russian roulette- nobody knows how severe the side effects will be. The drug companies lie, the psychiatrists deceive, there are vested interests hell bent on keeping the extent of the damage of these drugs hidden and obscured. Depression does not make people violent or volatile, but SSRI’s can induce these affects in those who take them- it is only since the advent of the SSRI anti-depressant age that we have witnessed so many cases like the Clancy case. This is not fiction, conspiracy theories or random accounts, these are documented cases. These are facts.

I hope that this documentary gives a fair and objective account of SSRI dangers, but I have a feeling that the drug companies and psychiatry will do everything in their power to defend the drugs and blame Shane. Psychiatry always blames the patient, and psychiatry is the pharmaceutical industry’s apologist. That’s a well known fact. Psychiatry and the pharmaceutical industry are two branches of the same tree, intertwined.

I look forward to blogging more after the documentary is aired. But for now I will leave these videos here about SSRI’s, violence, volatility, and disturbing side effects, they are essential viewing. (there are hundreds more on youtube)

Like this:

Irish broadcaster Pat Kenny regularly carts out the Irish Biological Psychiatrist Jim Lucey on his radio show. I’ve been listening (and reading between the lines) of his interviews. They can be listened to (and downloaded) on this link:

One that is particularly interesting is “Does Depression Really Exist?“.

In this interview , Lucey admits that Psychiatric Diagnosis isn’t about addressing the cause, he says it’s about diagnosing the symptoms in order to label depression.

One listener asked a question, “would I be on Effexor for the rest of my life”? “I’m worried and I don’t know what to do”.

Lucey seems to think that if someone has 3 re-current depressions due to stopping treatment- which he calls re-lapses- that they should stay on medication.

What Jim Lucey doesn’t say is- SSRI medications – like Effexor- can cause a withdrawal syndrome which mimics and often increases symptoms of depression and anxiety- therefore how does a psychiatrist diagnose re-lapse and differentiate between re-lapse into depression and SSRI withdrawal induced depression?

While I don’t doubt Jim Lucey believes in the biological model of psychiatry – it amazes me how he fails to see the dangers of prescribing a one-size-fits-all model for depression. Not once does he offer other alternatives- such as changes in diet, exercise, alternative therapies, nutrition, psychotherapy etc.

What Jim Lucey doesn’t address is the cause of depression in the first place- many factors which he mentions- such as grief, life-changes, environmental factors etc- he brushes over these and sees the individual purely in terms of symptoms instead of focusing on the root-cause.

Until the root cause of the depression is dealt with- chemical band-aid psychiatric drugs will not aid an individual in overcoming their depression. I speak from experience..

Discussing Mental Health entirely in biological terms, and aiming to treat Mental Health solely in chemical treatments, is extremely limited and does a great disservice to sufferers of depression and anxiety. Chemical treatments have clearly failed the majority of mental health sufferers, and perhaps it’s time that psychiatrists like Jim Lucey begin to see beyond the symptoms, the diagnosis and the ‘disease’, and into the essence of the individual.

The individual holds the key to their own recovery, but it seems psychiatrists like Jim Lucey are intent just on elevating their own status as experts on the human suffering of the patient, which is a process which while positive for his profession (in terms of validating the psychiatric ideology)- it results in dis- empowerment of the individual, therefore is negative for mental health sufferers.

On RTE radio on Monday at the end of a debate on autism, Pat Kenny’s resident psychiatrist Prof Jim Lucey said Dr Gilsenan’s views were “a classic example of a single dimensional divide” that occurs in the suicide debate.

Not sure exactly what that means, but he went on to say there is “no evidence” that anti-depressants cause suicide, and referred to an “anti-psychiatry movement”. Prof Lucey instead preferred to blame alcohol for a rise in suicide. I was under the impression that we Irish had always drunk copious amounts, so why all of a sudden is it driving us to suicide? Perhaps the issue of alcohol mixed with legally prescribed drugs would be a more valid argument. Coroners up and down the country have been commenting on the number of cases where legally prescribed drugs are a factor in deaths.

Jim Lucey says that there is no evidence that anti-depressants cause suicide. This is blatantly untrue. Perhaps Mr Lucey would like to take a look at the tens of thousands of stories of SSRI induced suicide, murder and aggression on SSRI Stories- http://ssristories.com/

or maybe he would open his mind and read about the coroners reports of SSRI induced suicides on this website:

A case presently being played out in a Netherlands Court involves a man who killed two people: his girlfriend, and a policeman who was responding to the emergency call.

Mr Asalam S. was taking Paroxetine (AKA Paxil and Seroxat) at the time of the killings. He is originally from Benin in Africa and at the time of the killings (April 2011), he had recently had his asylum application refused. The incident occured in the village of Baflo, which led to the perpetrator being dubbed as ‘The Beast of Baflo’.The trial continues in the Groningen courts tomorrow (Monday 11 Feb).

Last week, testimony regarding the dangers of anti-depressants was offered to the court by professor of pharmacology Dr. Anton Loonen. Prof/Dr. Loonen from the University of Gronengen, stated that this drug can lead to violent outbursts. The newspaper reported that Mr Asalam S. told his doctor that he was feeling unwell, which subsequently led to his dosage of Paroxetine being increased. As we know this can lead to tragic consequences. According to statements made by officers he acted ‘like a zombie’ and someone who ‘had nothing to lose’.

No doubt GlaxoSmithKline will have their ‘experts’ attending. It’s unfortunate for them that they have a dubious history; what telling the truth means to GSK, means something entirely different to the general public! This pharma company (GSK) were previously held liable in the case of Donald Schell, 60, who had been taking Paxil for just 48 hours when he shot and killed his wife, his daughter, his granddaughter and himself. You can download a copy of the verdict here.

This is not the first time that the Netherlands have come across an alleged ‘Seroxat induced’ killing. There was the so-called ‘axe murders’ which happened in Badhoevedorp in 2008. A former flight attendant Elzelien K. (aged 66) killed her husband, 61, and daughter, 22, as they slept. She had been ’depressed’ since her son had died in an accident 10 years beforehand but had recently started on a high dosage of Seroxat. During the trial, Elzelien K. said her actions were an ‘unimaginable mystery’ and ‘they were everything to me’. Dutch article here.

In a recent post Professor Healy stated that the information about SSRI induced disinhibition, violence and suicide has been in the public domain for nearly 25 years. He also stated:

“Somewhere around 90% of the school or other mass shootings that have happened in recent years in America or Europe have involved shooters on psychotropic drugs usually antidepressants. The public sympathy for the victims typically also extends to the doctor who is seen as one more victim. But the so called perpetrator is much more likely to be a victim than the doctor. He may have been turned into a guided missile by his doctor. These are people in treatment whose doctors clearly failed to recognize the risks they posed.”

So as more and more experts warn of the dangers of SSRIs, the inaction by the the EU is increasingly baffling. Of course, it’s not just Seroxat which has the potential for suicide and homicide. All SSRIs can cause suicide, violence. akathisia, worsening depression, ect, ect. Five days after first taking Celexa, Robert Raines, 78, shot and killed his wife, Elsie, 71, then himself. Article here. These cases will go on and on until something is done to hold the different pharmaceutical companies responsible.

It will certainly be interesting to see what happens in the Groningen courtroom. No doubt the pharma experts muppets will tow the company line. What is Glaxo’s motto? Oh yes; “enabling people to do more, feel better and live longer”. Tell that to the Seroxat victims!

Many thanks to Noel McCullagh, an Irish journalist living in the Netherlands, for the translating/reporting of this story.

“Drug induced death is the leading cause of death within the mental health field.” (Dr David Healy)

The delegation whom met with Minister Lynch included, the mother of SSRI casualty Shane Clancy, SSRI critic and patient advocate, Dr. David Healy, Former Minister for mental health (who was hounded out of office by Irish psychiatry some years ago), pharmacist and politician – Tim O’Malley – and former state pathologist, Dr Declan Gilsenan (whom is of the belief that SSRI’s are implicated far too often in suicide cases which he has studied). If that doesn’t wake up the Irish government to the truth about SSRI’s and the lies of Irish psychiatry (most of whom work for pharmaceutical companies), then I don’t know what will!!!! …

Today we met with Kathleen Lynch, the minister with responsibility for mental health. After the initial niceties, the first point she made was that she saw the article in the Examiner and she was hoping that the meeting today would be kept private and out of the public domain. This she said, was due to the other families who were also involved and she hoped that we could keep this an “in house and very much a private meeting.”

Sorry, I will not be playing the political game.

I disagree with Minister Lynch and I am of the opinion that keeping these issues a secret is exactly where the problem began. Did the Minister think that she had to remind us that there were other people involved? No poo sherlock!!

I personally know of a previous meeting in the Dail where the suicidal/aggression side-effects of SSRI’s were brought to the attention of a Government Minister. Maybe if something was done about the situation at that time, there wouldn’t be other people involved and Shane would be off traveling the world. But nothing was done, so we will never know, will we?

Declan Gilsenan was great; he spoke about his ‘intuition’ that SSRI’s are causing suicides and that the way to prove or disprove this would be to get statistics done on suicide victims. This, he said, wouldn’t be too difficult. He also brought the manual which the medical professionals learn from, which clearly state that SSRI’s can cause suicide. He asked if more suicide victims had sought help and therefore been prescribed SSRI’s, than people who didn’t. Imagine what a tragedy that would be?

Professor Healy was brilliant as always and spoke of the SSRI trials that were done on non-depressed people who went on to become suicidal once the drug was introduced and were fine again once the drug was discontinued. This he said is denied by the Irish College of Psychiatry. No surprise there then? He further stated that drug induced death is the leading cause of death within the mental health field.

At the end of the meeting Minister Lynch assured us that she would take all our points on board and bring them to the attention of the Minister for Health, James Reilly. This is the same James Reilly that previously stated “SSRIs aren’t addictive and treat depression effectively.” He also denied that GPs were systematically over-prescribing SSRIs. Minister Lynch also said she would be talking to the College of Psychiatry of Ireland again and intended to talk to them about the whole education piece. This is the same College of Psychiatry which collectively deny that SSRI’s can cause suicide despite the fact that the drug companies have to admit that they can?

I won’t be holding my breath but you never know! “Drug induced death is the leading cause of death within the mental health field.” Can this really be ignored? Antidepressants can cause suicide…Can this possibly be ignored?

Once again the adverse effects of antidepressants have been brought to the attention of the Irish Government, this time by the experts; the ball is firmly in their court!

When an autopsy expert with 30 years of experience suspects a possible link between suicide and the use of powerful anti-depressant drugs, it becomes a matter of the utmost concern and one that warrants immediate investigation.

The grave doubts expressed by former assistant state pathologist Dr Declan Gilsenan lend considerable weight to calls for action on this controversial issue. The authorities would be failing in their duty of care to the public if they do not heed his concerns over the number of suicide cases where he had carried out autopsies on victims who had recently started taking the anti-depressants in question.

Known collectively as SSRIs, they include popular drugs such as Prozac, Zoloft, Lexapro, Paxil, and Celexa, which are available on prescription from a GP. Significantly, fears about a suspected connection between suicides and this family of drugs arise at a time when a frightening number of young Irish men are taking their own lives. This fully justifies his call for doctors to be more careful about prescribing and for people to be monitored more carefully.

Dr Gilsenan, who retired last year, says he has seen “too many suicides” among people who had started taking the drugs. In his considered view the evidence was “more than anecdotal” and he now hopes to raise the matter with Kathleen Lynch, minister of state with responsibility for mental health.

An urgent meeting with the minister is being sought by a delegation organised by campaigner Leonie Fennell, whose son took his own life after killing a friend, having just started a course of anti-depressants. He is believed to have taken more than the prescribed amount. Since her son’s death, Ms Fennell has campaigned tirelessly to raise awareness about the potential dangers of anti-depressants.

This controversy is further complicated by the claims and counterclaims of a long-running row between doctors and psychiatrists over the use of such drugs.

According to Prof David Healy, the pharmaceutical industry is being protected by psychiatry. He accuses psychiatrists of coming out in defence of the drugs being used, and of regularly offering apologies for industry.

If Dr Gilsenan is right, there can be no denying that in the public interest, action is required to resolve this controversy once and for all. It should be easy enough to establish if statistical grounds exist to corroborate his assertion of possible connections between suicide and the use of powerful anti-depressants.

There is an onus on the minister to meet the proposed delegation sooner rather than later. Nor should she hesitate to take action to resolve this controversy and put people’s minds at ease. With lives possibly at stake, it is imperative to examine the concerns voiced by Dr Gilsenan without fear or favour.